A Study of VEGF-Antisense Oligonucleotide in Combination With Pemetrexed and Cisplatin for the Treatment of Advanced Malignant Mesothelioma

Inclusion Criteria

• •Patients must have histologically or cytologically confirmed malignant pleural mesothelioma, epithelial, sarcomatoid, or mixed subtype
• •Patients must have measurable disease,using RECIST criteria.Pleural effusions and ascites are not considered measurable lesions.
• •Patients with pleural mesothelioma must be IMIG stage ≥II
• •Age greater than or equal to 18 years.
• •ECOG performance status less than or equal to 2 and an estimated survival of at least 3 months
• •Patients must have adequate organ and marrow function as defined below:
• •Absolute neutrophil count greater than or equal to1,500 Platelets greater than or equal to 100,000 Total bilirubin less than or equal to2.0x the upper limits of institutional normal AST/ALT less than or equal to 2.0x the upper limits of institutional normal Creatinine Clearance greater than 50ml/min
• •The effects of VEGF-AS on the developing human fetus are unknown.
• •Pemetrexed may cause fetal harm when administered to a pregnant woman and is classified pregnancy category D. There are no studies of pemetrexed in pregnant women. Cisplatin is also categorized as FDA Pregnancy Category D. There is positive evidence of human fetal risk. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
• •Ability to understand and the willingness to sign a written informed consent.
• •Patients with history of prior cured malignancy \> 5 years since the completion of treatment may be accrued provided that other eligibility criteria are met.